中英文双语专刊：农药登记管理办法

中华人民共和国农业部令2017年第3号

Ministry of Agriculture Order No. 3，2017

农药登记管理办法

Measures on the Management of Pesticide Registration

第一章 总 则

Chapter I General

第一条 为了规范农药登记行为，加强农药登记管理，保证农药的安全性、有效性，根据《农药管理条例》,制定本办法。

Article 1 To regulate pesticide registration practices, strengthen pesticide registration management, ensure the safety and effectiveness of pesticides, the Pesticide Registration Management Measures (hereinafter referred to as the Measures) are hereby developed in accordance with the Regulations on the Management of Pesticides.

第二条 在中华人民共和国境内生产、经营、使用的农药，应当取得农药登记。

Article 2 The Measures shall apply to the registration of pesticides produced, operated and used in the territory of the People's Republic of China.

未依法取得农药登记证的农药，按照假农药处理。

A pesticide for which a pesticide registration certificate is not obtained according to the law will be deemed as a fake pesticide.

The pesticide examination institutions under the agricultural authorities at the provincial level (hereinafter referred to as pesticide examination institutions at the provincial level) shall provide assistance in dealing with specific issues concerning pesticide registration.

Article 6 The registration of safe, highly efficient and economical pesticides shall be encouraged, and the elimination of pesticides carrying high risks against agriculture, forestry, human and animal health, quality and safety of agricultural products and the environment shall be accelerated.

Article 7 Pesticides shall be named in common names in Chinese or abbreviations thereof. Botanical pesticides may be named in the form of "plant name + extract", and public health pesticides for direct use shall be named in the form of function description expressions and formulations.

第八条 农药有效成分含量、剂型的设定应当符合提高质量、保护环境和促进农业可持续发展的原则。

Article 8 The content of active ingredient and formulation of a pesticide shall be determined in the principles of improving quality, protecting the environment and promoting the sustainable development of agriculture.

The formulas of formulated products shall be scientific, reasonable and convenient for use. For a single formulation with the same active ingredient and formulation type, the contents of active ingredients shall be no more than three. There should be no more than two kinds of active ingredients in the pesticide ready-mixture, and no more than three kinds of active ingredients in herbicide, seed treatment, and pheromones; for ready-mixtures with the same active ingredients and formulation type, the ratio shall be no more than three, and the content gradients of the same ratio shall be no more than three. Pesticides with a low content of active ingredients that are directly used other than through dilution or dispersing shall be classified separately, specific relevant requirements will be developed separately by the Ministry of Agriculture.

第九条 农业部根据农药助剂的毒性和危害性，适时公布和调整禁用、限用助剂名单及限量。

Article 9 Based on the toxicity and harmfulness of pesticide adjuvants, the Ministry of Agriculture will timely publish and adjust the list and limited quantity of the prohibited/restricted adjuvants.

使用时需要添加指定助剂的，申请农药登记时，应当提交相应的试验资料。

Where a specified adjuvant needs to be added in pesticideswhen used, corresponding testing data shall be submitted in the application for pesticide registration.

第十条 农药产品的稀释倍数或者使用浓度,应当与施药技术相匹配。

Article 10 The dilution ratio or use concentration of pesticides shall match the techniques for applying pesticides.

第十一条 申请人提供的相关数据或者资料，应当能够满足风险评估的需要，产品与已登记产品在安全性、有效性等方面相当或者具有明显优势。

Article 11 Relevant data or materials submitted by the applicant shall meet the requirements of risk assessment, and demonstrate that its products are comparable or obviously superior to the registered products regarding safety, effectiveness, etc.

对申请登记产品进行审查，需要参考已登记产品风险评估结果时，遵循最大风险原则。

In the review of a product for which the registration is applied, it is required to refer to its risk assessment results and comply with the principle of maximum risks.

第十二条 申请人应当同时提交纸质文件和电子文档，并对所提供资料的真实性、合法性负责。

Article 12 The applicant shall submit both paper and electronic files, and be responsible for the authenticity and legality of the data provided.

第三章 申请与受理

Chapter III Application and Acceptance

第十三条 申请人应当是农药生产企业、向中国出口农药的企业或者新农药研制者。

Article 13 The applicant shall be a pesticide production enterprise, an enterprise exporting pesticides to China or a new pesticide developer.

A pesticide production enterprise refers to a domestic enterprise holding a pesticide production permit. An enterprise exporting pesticides to China (hereinafter referred to as an overseas enterprise) refers to an enterprise exporting the pesticides produced overseas to China. A new pesticide developer refers to a Chinese citizen, legal person or other organization applying for a new pesticide registration.

多个主体联合研制的新农药，应当明确其中一个主体作为申请人，并说明其他合作研制机构，以及相关试验样品同质性的证明材料。其他主体不得重复申请。

For new pesticides jointly developed by several entities, one of the entities shall act as the applicant, specify other joint R&D institutions and provide supporting materials to prove the homogeneity of the relevant test samples. Other entities shall not make repeated applications.

第十四条 境内申请人向所在地省级农业部门提出农药登记申请。境外企业向农业部提出农药登记申请。

Article 14 A domestic applicant shall apply for pesticide registration to the agricultural authority at the provincial level where it is located. An overseas enterprise shall apply for pesticide registration at the Ministry of Agriculture.

Article 16 A registration test report shall be issued by the registration test agency approved by the Ministry of Agriculture, or issued by a relevant overseas laboratory under the mutual recognition agreement between the relevant departments of government, provided that the efficacy, residue, environment and other tests closely related to environmental conditions as well as registration tests for unique biological species to China shall be completed in the territory of China.

第十七条 申请新农药登记的，应当同时提交新农药原药和新农药制剂登记申请，并提供农药标准品。

Article 17 The applicant, if applying for new pesticide registration, shall submit the registration applications for both new pesticide TC and new pesticide formulations, as well as reference samples of the pesticides.

自新农药登记之日起六年内，其他申请人提交其自己所取得的或者新农药登记证持有人授权同意的数据申请登记的，按照新农药登记申请。

Within six years upon registration of the new pesticide, where other applicants submit applications with the data obtained by themselves or authorized by the new pesticide registration certificate holder, it shall be deemed as a new pesticide registration application.

第十八条 农药登记证持有人独立拥有的符合登记资料要求的完整登记资料，可以授权其他申请人使用。

Article 18 The complete registration data consistent with the registration data requirements and owned independently by the pesticide registration certificate holder may be used by other applicants if so authorized.

按照《农药管理条例》第十四条规定转让农药登记资料的，由受让方凭双方的转让合同及符合登记资料要求的登记资料申请农药登记。

Where the pesticide registration data is transferred according to Article 14 of the Regulations on the Management of Pesticides, the transferee shall apply for pesticide registration by virtue of the transfer contract between the parties and the registration data consistent with registration data requirements.

第十九条 农业部或者省级农业部门对申请人提交的申请资料，应当根据下列情况分别作出处理：

Article 19 For the application data submitted by the applicant, the Ministry of Agriculture or the agricultural authority at the provincial level shall treat it based respectively on the following circumstances:

（一）不需要农药登记的，即时告知申请者不予受理；

(I) Where no pesticide registration is required, the applicant shall be timely informed that is application is not accepted;

（二）申请资料存在错误的，允许申请者当场更正；

(II) Where an error is found in the application data, the applicant shall be allowed to correct it on site;

(III) Where the application data is not complete or consistent with legal forms, the applicant shall be informed of all the contents that should be corrected or supplemented on site or one time within five working days; if the applicant is not informed within the aforesaid period, the data is deemed as accepted upon receipt of the application data;

（四）申请资料齐全、符合法定形式，或者申请者按照要求提交全部补正资料的，予以受理。

(IV) Where the application data is complete, consistent with legal forms, or where the applicant submitted all supplemental or corrected data as required, the application shall be accepted.

Article 20 The agricultural authorities at the provincial level shall perform a preliminary examination of the data submitted by an applicant within twenty working days upon acceptance of such application, give opinions of the preliminary examination, and report to the Ministry of Agriculture. If not qualified following the preliminary examination, a written notice indicating the reasons will be given to the applicant in accordance with the will of the applicant.

Article 21 Upon acceptance of the application or receipt of the application data and preliminary examination opinions submitted by the agricultural authorities at the provincial level, the Ministry of Agriculture shall complete technical examinations on the chemistry, toxicity, efficacy, residue, environment impact and label sample of the product within nine months, give examination opinions, and submit them to the Pesticide Registration Reviewing Committee for review.

Article 23 Upon acceptance of the pesticide registration application, the applicant may withdraw the registration application and submit a new application when supplementing and completing the relevant data.

农业部根据农药登记评审委员会意见，可以要求申请人补充资料。

The Ministry of Agriculture may require the applicant to supplement data based on the opinions of the Pesticide Registration Reviewing Committee.

Article 24 During registration examination and review, the category of registration application submitted by the applicant and the technical requirements and review procedures that the applicant follows will not be affected by the other applicant's obtaining of a pesticide registration certificate during this period.

After a new pesticide is approved, the new pesticide registration application from any other applicant which has been accepted can continue to be subject to examination and review according to new pesticide registration approvals and review procedures. Other applicants may withdraw the application and file a new registration application.

第二十五条 农业部自收到评审意见之日起二十个工作日内作出审批决定。符合条件的，核发农药登记证；不符合条件的，书面通知申请人并说明理由。

Article 25 The Ministry of Agriculture shall make a decision within twenty working days upon receipt of the review opinions. If the conditions are met, the pesticide registration certificate shall be issued, and if not, a written notice indicating the reasons shall be given to the applicant.

第二十六条 农药登记证由农业部统一印制。

Article 26 The pesticide registration certificate shall be uniformly printed and issued by the Ministry of Agriculture.

第五章 变更与延续

Chapter V Change and renewal of Registration

第二十七条 农药登记证有效期为五年。

Article 27 The pesticide registration certificate shall be valid for five years.

第二十八条 农药登记证有效期内有下列情形之一的，农药登记证持有人应当向农业部申请变更：

Article 28 The holder shall apply for change at the Ministry of Agriculture in the event one of the following circumstances occurs during the validity of the pesticide registration certificate:

（一）改变农药使用范围、使用方法或者使用剂量的；

(I) the scope, method or use dosage of the pesticide is changed;

（二）改变农药有效成分以外组成成分的；

(II) the components, except for the active ingredients, are changed;

（三）改变产品毒性级别的；

(III) the toxicity level of the product is changed;

（四）原药产品有效成分含量发生改变的；

(IV) the content of active ingredients in the TC is changed;

（五）产品质量标准发生变化的;

(V) product quality standards are changed;

（六）农业部规定的其他情形。

(VI) other circumstances specified by the Ministry of Agriculture.

变更农药登记证持有人的，应当提交相关证明材料，向农业部申请换发农药登记证。

In case of change to the pesticide registration certificate holder, relevant proof shall be submitted to the Ministry of Agriculture for the re-issuing of a pesticide registration certificate.

第二十九条 有效期届满，需要继续生产农药或者向中国出口农药的，应当在有效期届满九十日前申请延续。逾期未申请延续的，应当重新申请登记。

Article 29 Where the production of pesticides or export of pesticides to China needs to be continued upon expiration of the validity period, an application for renewal shall be made ninety days before expiration of the validity period. If no renewal is applied within such time limit, the application for registration shall be submitted again.

第三十条 申请变更或者延续的，由农药登记证持有人向农业部提出，填写申请表并提交相关资料。

Article 30 In case of application for change or renewal, the pesticide registration certificate holder shall submit such an application to the Ministry of Agriculture, fill in the application form and submit relevant data.

Article 31 The Ministry of Agriculture shall finish the examination on the registration change within six months, give examination opinions, submit them to the Pesticide Registration Reviewing Committee for review, and make a decision within twenty working days upon receipt of the review opinions. If the application is qualified, the registration change will be permitted, with the registration certificate number and validity term unchanged; if not, a written notice indicating the reasons will be given to the applicant.

Article 32 The Ministry of Agriculture shall examine the registration renewal application materials, and make a decision on whether the renewal should be allowed before expiration of the validity period. If any hidden danger or risk is found in safety and effectiveness, the materials shall be submitted to the Pesticide Registration Reviewing Committee for review.

Article 34 The content to be monitored shall include the impacts of pesticides on agriculture, forestry, human and animal safety, agricultural product quality and safety, the environment, etc.

有下列情形之一的，应当组织开展评价：

The evaluations shall be organized and performed in case of any one of the following circumstances:

（一）发生多起农作物药害事故的；

(I) many crop phytotoxicity accidents occur;

（二）靶标生物抗性大幅升高的；

(II) the target biotic resistance is greatly raised;

（三）农产品农药残留多次超标的；

(III) the pesticide residue of agricultural products exceeds the standard value a number of times;

（四）出现多起对蜜蜂、鸟、鱼、蚕、虾、蟹等非靶标生物、天敌生物危害事件的；

(IV) harmful events are caused to non-target species and natural enemy organisms, such as bees, birds, fish, silkworms, shrimps and crabs;

（五）对地下水、地表水和土壤等产生不利影响的；

(V) an adverse impact occurs in underground water, surface water and soil, etc.;

（六）对农药使用者或者接触人群、畜禽等产生健康危害的。

(VI) harm occurs to the health of pesticide users or the persons and animals exposed to the pesticide.

省级农业部门应当及时将监测、评价结果报告农业部。

The agricultural authorities at the provincial level shall report the monitoring and evaluation results to the Ministry of Agriculture in a timely manner.

第三十五条 农药登记证持有人应当收集分析农药产品的安全性、有效性变化和产品召回、生产使用过程中事故发生等情况。

Article 35 The pesticide registration certificate holder shall collect the information of and analyze the safety, efficacy change, product recall, accidents in production and use, etc. of pesticide products.

第三十六条 对登记十五年以上的农药品种，农业部根据生产使用和产业政策变化情况，组织开展周期性评价。

Article 36 For pesticide products with a registration of more than fifteen years, the Ministry of Agriculture shall organize periodic evaluations based on the changes of production and use situations and industry policies.

Article 37 If any registered pesticide is found to have caused serious harm or brings high risks to agriculture, forestry, human and animal safety, agricultural product quality and safety, the environment, etc., the Ministry of Agriculture shall organize the Pesticide Registration Reviewing Committee to perform reviews, cancel or alter the corresponding pesticide registration certificate based on the review results, and if necessary, the use shall be prohibited or restricted and an announcement shall be published.

第七章 监督管理

Chapter VII Monitoring and Management

第三十八条 有下列情形之一的，农业部或者省级农业部门不予受理农药登记申请；已经受理的，不予批准：

Article 38 In case of any of the following circumstances, the Ministry of Agriculture or agricultural authorities at the provincial level shall refuse to accept the pesticide registration application, and if having already accepted it, shall disapprove it if:

（一）申请资料的真实性、完整性或者规范性不符合要求；

(I) the application data is not consistent with requirements regarding authenticity, completeness or standardization;

（二）申请人不符合本办法第十三条规定的资格要求；

(II) the applicant is not qualified as specified in Article 13 of the Measures;

（三）申请人被列入国家有关部门规定的严重失信单位名单并限制其取得行政许可；

(III) the applicant is on the list of institutions with a history of serious dishonest acts as specified by competent authorities of the state and is restricted from obtaining an administrative permit;

（四）申请登记农药属于国家有关部门明令禁止生产、经营、使用或者农业部依法不再新增登记的农药；

(IV) the pesticides for registration are clearly prohibited for production, operation and use by relevant national authority, or the pesticides are no longer registered according to the law by the Ministry of Agriculture;

（五）登记试验不符合《农药管理条例》第九条第三款、第十条规定;

(V) the registration test is against Paragraph III, Article 9 and Article 10 of the Regulations on the Management of Pesticides;

（六）应当不予受理或者批准的其他情形。

(VI) other circumstances where the applicant shall not be accepted or approval shall not be granted.

Where an applicant conceals relevant facts or submits fake pesticide registration data and test samples, his/her application will not be entertained for one year; if the registration has been approved, the pesticide registration certificate shall be withdrawn and his/her application will not be entertained for three years. Where the pesticide registration certificate is revoked, his/her application will not be entertained for five years.

第三十九条 对提交虚假资料和试验样品的，农业部将申请人的违法信息列入诚信档案，并予以公布。

Article 39 The Ministry of Agriculture will list the tainted information of the applicant submitting fake data and test samples into the integrity record and publish it.

第四十条 有下列情形之一的，农业部注销农药登记证，并予以公布：

Article 40 The Ministry of Agriculture shall cancel the pesticide registration certificate and publish the fact in any of the following circumstances:

（一）有效期届满未延续的；

(I) the application for renewal is not filed upon expiration of the validity term;

（二）农药登记证持有人依法终止或者不具备农药登记申请人资格的；

(II) the pesticide registration holder is terminated according to law or not qualified as a pesticide registration application;

（三）农药登记资料已经依法转让的；

(III) the pesticide registration data has been transferred according to law;

（四）应当注销农药登记证的其他情形。

(IV) other circumstances where the pesticide registration certificate shall be canceled.

Article 41 construction of a pesticide registration information platform, gradually realizes online handling of registration applications, and publishes the pesticide registration certificate issuing, renewal, changes, withdrawals and cancellation information, as well as the approved label information about the quality standard code, residue limit and testing methods of pesticide products through the website of the Ministry of Agriculture or by issuing a pesticide registration announcement.

Article 42 Where any member of the Pesticide Registration Reviewing Committee seeks personal benefits during the application process, the Ministry of Agriculture will remove the member from the Pesticide Registration Reviewing Committee; where the member is a state functionary, he/she shall be submitted to the relevant authority for punishment according to the law; where his/her act constitutes a crime, he/she shall be held liable criminally.

Article 43 The Ministry of Agriculture, agricultural authorities at the provincial level and their personnel engaged in pesticide registration shall perform their duties according to the law, give scientific, objective and fair examination and review opinions, and are obligated to keep confidential the registration data submitted by the applicant, and unpublished examination and review results and opinions. If the government authority or personnel has any personal relation with or any special interest regarding any applicant or the corresponding products (data), he/she shall avoid participating in pesticide production and operation activities.

Article 44 Where any personnel engaged in pesticide registration fails to perform their duties, misuses their authority, plays favoritism and commits irregularities, or asks for, accepts properties, or seeks other interests, the personnel shall be punished accordingly; upon the day when the punishment is made, the personnel shall not be engaged in pesticide registration work for five years.

Article 45 If any unit or individual finds any circumstance against the Measures, it has the right to report to the Ministry of Agriculture or agricultural authority at the provincial level. The Ministry of Agriculture or agricultural authority at the provincial level shall verify such reporting and deal with the circumstance in a timely manner. Furthermore, the Ministry of Agriculture shall keep confidential the information of the informer. If the case is verified to be true, plays an active role in production safety or saves great loss, a reward or award shall be given according to relevant national regulations.

第八章 附 则

Chapter VIII Supplementary Provisions

第四十六条 用于特色小宗作物的农药登记，实行群组化扩大使用范围登记管理，特色小宗作物的范围由农业部规定。

Article 46 For the registration of pesticides used for special minor crops, grouped registration management shall apply to the expanded use scope. The scope of special minor crops is determined by the Ministry of Agriculture.

For special minor crops or new pests to which no registered pesticides are available, the agricultural authorities at the provincial level may take temporary pesticide application measures based on local actual situation and submit them to the Ministry of Agriculture for recording.

第四十七条 本办法下列用语的含义是：

Article 47 The terms used in the Measures shall be defined as follows:

（一）新农药，是指含有的有效成分尚未在中国批准登记的农药，包括新农药原药（母药）和新农药制剂。

(I) a new pesticide refers to the pesticide that contains any active ingredient not approved and registered in China, including new pesticide TC (TK) and new pesticide formulations;

（二）原药，是指在生产过程中得到的由有效成分及有关杂质组成的产品，必要时可加入少量的添加剂。

(II) TC refers to the product obtained from the production process and composed of active compounds and relevant impurities, and if necessary, containing a small volume of additives;

（三）母药，是指在生产过程中得到的由有效成分及有关杂质组成的产品，可含有少量必需的添加剂和适当的稀释剂。

(III) TK refers to the product obtained from the production process, composed of active compounds and relevant impurities, and possibly containing a small volume of necessary additives and moderate diluents;

（四）制剂，是指由农药原药（母药）和适宜的助剂加工成的，或者由生物发酵、植物提取等方法加工而成的状态稳定的农药产品。

(IV) formulation refers to stable pesticide products processed from TC (TK) and appropriate adjuvants or processed by way of biological fermentation, phytoextraction, etc.;

(V) adjuvant refers to any substance (other than the active compound) composed of a single component or several components which is added into a pesticide product and has no pesticide activity and active compound functions in itself, but is able or helpful to improve or enhance the material properties of pesticide products.

第四十八条 仅供境外使用农药的登记管理由农业部另行规定。

Article 48 The registration management of the pesticides only used overseas shall be subject to separate regulations under the Ministry of Agriculture.

第四十九条 本办法自2017年8月1日起施行。

Article 49 The Measures are enacted as from August 1, 2017.

2017年6月1日之前，已经取得的农药临时登记证到期不予延续；已经受理尚未作出审批决定的农药登记申请，按照《农药管理条例》有关规定办理。

Before June 1, 2017, temporary pesticide registration certificates already obtained will not be renewed upon expiration. The pesticide registration applications that are already accepted but not yet approved will be subject to relevant provisions in the Regulations of the Management of Pesticides.